A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis (NCT04207801) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study to Evaluate Efficacy & Safety of AUR101 in Patients of Moderate-to-Severe Psoriasis
India90 participantsStarted 2020-01-21
Plain-language summary
This will be a multicenter, double-blind, double-dummy, placebo controlled, randomized study to evaluate efficacy and safety of AUR101 (RORgamma inhibitor) in patients with moderate-to-severe psoriasis.
Approximately 90 patients with chronic moderate-to-severe plaque psoriasis will be randomized to the 2 dose groups of AUR101 and one group of Placebo. The patients will receive the treatment for 12 weeks.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Confirmed diagnosis of chronic plaque-type psoriasis, diagnosed at least 6 months before screening
2\. Psoriasis of at least moderate severity, defined as PASI≥12 and involved BSA≥10 % at screening and Day 1
3\. Adult males or females,≥18 to ≤ 65 years of age.
4\. Ability to communicate well with the investigator and to comply with the requirements of the entire study
5\. Willingness to give written informed consent (prior to any study related procedures being performed) and ability to adhere to the study restrictions and assessments schedule.
Exclusion Criteria:
* 1\. History of erythrodermic, guttate, or pustular psoriasis within last 12 months
2\. Efficacy failure on any biologic (e.g. interleukin (IL) -17 antibodies or anti-TNF agents) for the treatment of psoriasis.
3\. Static 5-point IGA mod 2011 scale of 0 to 2 at screening or Day 1.
4\. BMI ≥ 35 kg/m2
5\. Current treatment or history of treatment for psoriasis with IL-17 or IL-12/23 antagonist biological agents within 6 months prior to study day 1
6\. Current treatment or history of treatment for psoriasis with other biological agents within 3 months prior to study day 1.
7\. Current treatment or history of treatment for psoriasis with non-biological systemic medications or phototherapy within 4 weeks prior to study day 1.
8\. Treatment with medicated topical agents within 2 weeks prior to study day 1.
9\. History or presence of any medical or psychiatri…
What they're measuring
1
Proportion of Patients Achieving Psoriasis Area and Severity Index (PASI) 75 (i.e. 75% Reduction From Baseline PASI Score). (Scores Range From 0 (Minimum) to 30 (Maximum))